Model Number 72404310 |
Device Problems
Collapse (1099); Inflation Problem (1310); Mechanical Problem (1384)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 03/19/2019 |
Event Type
Injury
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Manufacturer Narrative
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Additional product component: model number/catalog number: 72404012 and 72404161, serial number: null and null, batch/lot number 177775009 and 174269006, model/catalog description: cxr 14cm and reservoir 65ml pc.
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Event Description
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It was reported that the patient experienced the pump staying flat and experiencing inflation issues with an inflatable penile prosthesis (ipp).The ipp pump, cylinder, and reservoir was explanted and a new ipp pump, cylinder, and reservoir was implanted.Should additional relevant details become available or the product was returned, a supplemental report will be submitted upon completion of product analysis.
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Manufacturer Narrative
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Device analysis: malfunction was reported.The ams700 device was visually inspected and functionally tested.No leak was found.The pump failed the 8 lb.Activation test and the inflation test.The pump required more than 8 lbs.Of force to activate.Based on a thorough review of the reported complaint, the most probable cause for this complaint was considered cause traced to component failure.This complaint investigation conclusion code is utilized for an expected or random component failure without any design or manufacturing issue.Based on the results of this investigation, no escalation is necessary.Additional product component: model number/catalog number, 72404012 and 72404161, serial number: null and null, batch/lot number: 177775009 and 174269006, model/catalog description: cxr 14cm and reservoir 65ml pc.
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Event Description
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It was reported that the patient experienced the pump staying flat and experiencing inflation issues with an inflatable penile prosthesis (ipp).The ipp pump, cylinder, and reservoir was explanted and a new ipp pump, cylinder, and reservoir was implanted.Should additional relevant details become available or the product was returned, a supplemental report will be submitted upon completion of product analysis.
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Search Alerts/Recalls
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